Microwave Ablation vs Radiofrequency Ablation in the Management of Complicated Monochorionic Pregnancies：A RCT Study

NCT04014452 | Unknown

• 1 other identifier: PekingUTHweiyuanRCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Complicated pregnancies refer some special complications, including twin to twin transfusion syndrome(TTTS), twin reverse arterial perfusion(TRAP), selective intrauterine fetal growth restriction(sIUGR), twin anemia-polycythemia sequence(TAPS), one fetal death or structural abnormalities, etc. Complicated twins are often associated with high perinatal morbidity and mortality. Severe complicated twins can be treated with fetal-reduction surgery during pregnancy, which can improve the survival rate of retained fetuses and reduce the disability rate. The managements include mechanical umbilical cord ligation or thermal coagulation obliteration, such as bipolar coagulation (BCC), radiofrequency ablation (RFA), and laser coagulation.Nowadays radiofrequency ablation reduction is the most common, which processes a higher survival rate and fewer maternal and fetal complications compared with other ways.Latest experience suggests that microwave ablation(MWA) is also easy to be used and the therapeutic effect is similar with RFA, but there is no convincing evidence. Compared with radiofrequency ablation, MWA has the advantages of simple operation and time, and avoids the problems of tissue carbonization, drying and heat sink effect. For fetation reduction surgery, the main advantage is that the endothermic effect near the blood vessels is smaller, which enables microwave fetation reduction to have a larger ablation range and a higher thermal effect. This study is comparing Microwave Ablation(MWA) and radiofrequency ablation (RFA) methods for selective fetal reduction in the treatment of complicated monochorionic (MC) multifetal gestations. This is a pilot randomised controlled trial(RCT) of 60 patients who undergo selective fetal reduction. The subjects of this study were all pregnant women and their offspring who underwent reduction surgery in the third hospital of Beijing University, and patients are randomly assigned 1:1 to different intervention groups by parallel design. The outcome evaluators were blind. Collecting their surgery, clinical information and maternal and fetal complications at a week and a month after surgery, 42 days and 6 months after delivery, to verify the safety and efficacy of MWA, and find a better treatment plan for complicated monochorionic pregnancies .The primary outcome was neonatal survival rate.

Conditions

Twin; Complicating Pregnancy; Microwave Ablation

Keywords

Complicated Monochorionic Pregnancies; Selective feticide

Outcome Measures

Primary Outcomes (1)

• Neonatal survival rate

  The proportion of live births at 28 days postpartum

  a month after delivery

Secondary Outcomes (4)

• Surgical injury to fetal

  at 28 weeks gestation

• Postoperative complications

  at delivery

• Perinatal outcomes

  a week after delivery

• Growth of the children

  6 months postpartum

Study Arms (2)

Microwave ablation group

EXPERIMENTAL

Microwave ablation is used for the treatment of Complicated Monochorionic Pregnancies

Procedure: Microwave ablation

Radiofrequency ablation group

ACTIVE COMPARATOR

Radiofrequency ablation is used for the treatment of Complicated Monochorionic Pregnancies

Procedure: Radiofrequency ablation

Interventions

Microwave ablation PROCEDURE

Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.

Microwave ablation group

Radiofrequency ablation PROCEDURE

Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.

Radiofrequency ablation group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Complicated monochorionic pregnancies women;
• Having the indication of selective reduction;(TTTS III or IV, TRAP, severe sIUGR, Twin malformation inconsistency or stillbirth，three or more fetuses with monochorionic pregnancies requiring reducing the number of fetuses）
• The reduction surgery should be done after 15 weeks of gestation;
• Willingness to participate in the trial and having provided written consent.

You may not qualify if:

• Preoperative examination shows that patient is not appropriate to undergoing reduction surgery, such as acute infection of the organ system, especially the urinary system.
• Patients need to perform acute reduction surgery due to the progress of the disease and the surgery cannot be scheduled.
• Other diseases that may affect the experimental results: neuropsychiatric diseases and congenital diseases.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Related Publications (1)

• Xie J, Cheng Z, Wu T, Wei Y, Wang X. Microwave ablation versus radiofrequency ablation for the treatment of severe complicated monochorionic pregnancies in China：protocol for a pilot randomised controlled trial. BMJ Open. 2020 Aug 13;10(8):e034995. doi: 10.1136/bmjopen-2019-034995.

  PMID: 32792427 DERIVED

MeSH Terms

Conditions

Pregnancy Complications

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Zeng Lin, Ph.D

  PRS administrator

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will seal the randomisation codes in sequentially numbered opaque envelopes and send them to the research centres. Allocation will be concealed until participants sign the informed consent, at which time the interventionalist will access the allocation code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2019
• First Posted: July 10, 2019
• Study Start: July 15, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Participant data after deidentification (text, table, figures, and appendices) and protocol will be shared beginning 9 months and ending 36 months following article publication
• Access Criteria: Requested data for public purpose or research transparency will be provided via the corresponding author.The e-mail address is weiyuanbysy@163.com.

Locations

CN (1)